BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6880000 · Received September 20, 2017

    Report

    Report Number
    1213809-2017-00139
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 29, 2017
    Report Date
    November 28, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7001975, MEDICAL DEVICE EXPIRATION DATE: 12/31/2021, DEVICE MANUFACTURE DATE: 01/19/2017, MEDICAL DEVICE LOT #: 7001978 , MEDICAL DEVICE EXPIRATION DATE: 12/31/2021, DEVICE MANUFACTURE DATE: 02/15/2017, MEDICAL DEVICE LOT #: 7060631, MEDICAL DEVICE EXPIRATION DATE: 02/28/2022, DEVICE MANUFACTURE DATE: 04/29/2017. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR (P/N 309658) BATCH 7001978, 7001975, 7060631. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: THREE SEALED 3ML SYRINGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM THREE DIFFERENT BATCHES: #7001978, 7001975 AND 7060631 (P/N 309658). NO DEFECTS WERE OBSERVED IN THESE SAMPLES. ONE LOOSE 3ML SYRINGE IN A SEALED SAMPLE BAG WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #7001978 OR 7001975 OR 7060631 (P/N 309658). THE SAMPLE WAS VISUALLY EVALUATED. THE SAMPLE WAS USED WITH HANDWRITTEN NOTES WARNING OF CYTOSTATICS. THE VISUAL EVALUATION WAS THEREFORE PERFORMED THROUGH THE SAMPLE BAG. THE SYRINGE HAD BLUE CAPPED NEEDLE ATTACHED, A BLUE GLOVE, AND LIQUID RESIDUE WAS OBSERVED IN AND AROUND THE SAMPLE. WHAT APPEARED TO BE A CRACK WAS OBSERVED RUNNING LENGTHWISE ON THE BARREL WALL, HOWEVER, IT COULD NOT BE PHYSICALLY CONFIRMED DUE TO THE USED NATURE OF THE SAMPLE. INVESTIGATION COULD NOT PROCEED FURTHER WITHOUT THE ABILITY TO BETTER EVALUATE THE DEFECT. ROOT CAUSE: UNDETERMINED - BASED ON THE INVESTIGATION RESULTS TO DATE, THE SOURCE OF FM COULD NOT BE DETERMINED AND ROOT CAUSE NOT FOUND. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CYTOSTASIS MEDICATION LEAKED FROM A BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658717 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other